|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 March 2024 |
|
Main ID: |
NCT02381886 |
|
Date of registration:
|
02/03/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
|
|
Scientific title:
|
A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations |
|
Date of first enrolment:
|
January 6, 2015 |
|
Target sample size:
|
166 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT02381886 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Australia
|
Belgium
|
Canada
|
Germany
|
Netherlands
|
Singapore
|
Spain
|
United States
|
|
Contacts
|
|
Name:
|
Novartis Pharmaceuticals |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharmaceuticals |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Documented IDH1R132-mutant tumors
- ECOG performance status = 2
Exclusion Criteria:
- Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with
the exception of glioma patients)
- Medical conditions that would prevent the patient's participation in the clinical
study due to safety concerns or compliance with clinical study procedures such as the
presence of other clinically significant cardiac, respiratory, gastrointestinal,
renal, hepatic or neurological disease.
- Acute Promyelocytic Leukemia
- Women who are pregnant or lactating
Other protocol-defined Inclusion/Exclusion may apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Advanced Malignancies That Harbor IDHR132 Mutations
|
|
Intervention(s)
|
|
Drug: IDH305
|
|
Primary Outcome(s)
|
|
Incident rate of dose limiting toxicities (DLTs)
[Time Frame: 21 days]
|
|
Secondary Outcome(s)
|
|
Overall response rate (ORR)
[Time Frame: 30 months]
|
|
Changes of 2-hydroxyglutarate concentration in patient specimens
[Time Frame: 30 months]
|
|
Incidence of adverse events (AEs)
[Time Frame: 30 months]
|
|
Incidence of serious adverse events (SAE)
[Time Frame: 30 months]
|
|
Plasma PK parameters (AUC, Cmax, Tmax)
[Time Frame: 30 months]
|
|
Secondary ID(s)
|
|
CIDH305X2101
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|